AUM Cardiovascular Receives FDA Approval for CADence ECG Device

August 8, 2017 — AUM Cardiovascular announced it has received clearance from the U.S. Food and Drug Administration (FDA) for CADence, a non-invasive acoustic and electrocardiogram (ECG) device designed to help physicians detect physiological and pathological heart murmurs.

The reusable, non-invasive, radiation-free handheld device, which is now available in the United States, records sounds originating from the patient's heart. Powered by a proprietary algorithm, special software crunches the acoustic data that is presented in a physician's report. The report allows a physician to determine the state of the patient's cardiovascular health. AUM also plans release of algorithms that crunch the same data to determine if arteries are clogged with plaque, a condition known as stenosis.

For primary care doctors, stenosis is particularly hard to detect because patients do not exhibit noticeable symptoms. Normal screening methods — measuring blood pressure and low-density lipoprotein (LDL) — are not good predictors of stenosis. Computed topography, magnetic resonance imaging and ultrasound can spot stenosis by measuring everything from thickness of artery walls to calcium deposits. But such technologies are expensive.

According to AUM's Turbulence clinical study, CADence performs just as well as a single-photon emission computed tomography (SPECT) nuclear stress test in ruling out obstructive coronary artery disease (CAD) in patients with chest pain and risk factors. AUM is pursuing clearance from FDA to market CADence for detection of CAD.

"The CADence system has the potential to dramatically enhance our ability to rule-out significant coronary artery disease and efficiently triage patients needing additional testing," said Jay Thomas, M.D., an interventional cardiologist at Harbor-UCLA Medical Center in Los Angeles, who oversaw the study.

"CADence is an exciting example of how novel technology will revolutionize patient care," Thomas said. "It is a rapid, cost-effective, radiation-free way to evaluate selected patients with chest pain. The need for something like CADence is quite obvious considering how we have managed chest pain testing for the last twenty years."